Your regulatory story matters
We support you
Whether you are a large multinational corporation, an emerging biotechnology firm, or a research institution, we tailor our services to your specific needs, helping you achieve regulatory excellence and drive your innovations forward.
Who we are
We are more than just a consultancy
Regulatory and Resourcing is dedicated to empowering pharmaceutical and biotechnology companies to thrive in an ever-evolving regulatory environment. With a client-focused approach and deep industry expertise, we will deliver innovative, strategic solutions tailored to meet your unique challenges.
With 30 years of experience in the pharmaceutical industry, our founder, Neama Baho, has successfully navigated countless products through the global regulatory landscape, from development to lifecycle management. Neama’s extensive experience includes working closely with health authorities and government bodies, where she has addressed policy challenges, reversed regulatory decisions, and negotiated favorable outcomes for patients. Complementing her technical expertise with an MBA, Neama’s deep understanding of business objectives has enabled her to resolve complex registrations and drive strategic solutions.
Neama’s proven track record of regulatory achievement, adaptive leadership, collaboration, and commitment to excellence has consistently created value and driven impactful change.
our expertise and services
Guiding you at every stage of the product journey
- We pride ourselves on blending strategic and operational insights to support Prescription Medicines, across a wide range of therapeutic areas, focusing on Australia and New Zealand. Our expertise in quality and manufacturing enables us to deliver holistic solutions that not only meet regulatory requirements but also align with your broader organizational goals.
- Every project receives the personalised attention it deserves.
End to end regulatory support
- Regulatory strategies
- Clinical trial applications
- Investigator’s brochures
- Orphan drug designations
- Priority and provisional determinations
- GMP clearances
- Labelling compliance
- Marketing authorisation submissions
- Health authority response management
- Life cycle maintenance submissions
Regulatory guidance
- We provide clear, actionable regulatory advice to ensure your projects are aligned with the latest requirements.
Health authority meetings
- We leverage our decades of experience with health authorities to prepare for and conduct effective meetings.
Training and upskilling
- We empower your team with a bespoke training approach that will transform their regulatory and leadership performance.
Your partner in pharmaceutical and biotechnology success
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